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... 41. For reasons of workability and because of their special nature, specific registration requirements should be laid down for intermediates. Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost-efficient way on the basis of sound technical and valid scientific criteria. ...
... 66. The Agency should also be empowered to require further information from manufacturers, importers or downstream users on substances suspected of posing a risk to human health or the environment, including by reason of their presence on the internal market in high volumes, on the basis of evaluations performed. Based on the criteria for prioritising substances developed by the Agency in cooperation with the Member States a Community rolling action plan for substance evaluation should be established, relying on Member State competent authorities to evaluate substances included therein. If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, the competent authorities of the Member States should also be allowed to require further information, when justified. ...
ARTICLE-2: Application [go to this ARTICLE]
... (c) non-isolated intermediates; ...
... 8. On-site isolated intermediates and transported isolated intermediates shall be exempted from: ...
... 8. On-site isolated intermediates and transported isolated intermediates shall be exempted from: ...
ARTICLE-3: Definitions [go to this ARTICLE]
... 15) Intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as "synthesis"): ...
... (a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture; ...
... (a) non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture; ...
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...
... (c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites; ...
... (c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites; ...
... (c) transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites; ...
ARTICLE-6: General obligation to register substances on their own or in preparations [go to this ARTICLE]
... 2. For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply. ...
... 2. For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply. ...
ARTICLE-17: Registration of on-site isolated intermediates [go to this ARTICLE]
... Registration of on-site isolated intermediates ...
... 1. Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate. ...
... 1. Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate. ...
... 2. A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing: ...
... (b) the identity of the intermediate as specified in sections 2.1 to 2.3.4 of Annex VI; ...
... (c) the classification of the intermediate as specified in section 4 of Annex VI; ...
... (d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted; ...
... 3. Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to minimise emission and any resulting exposure. If these conditions are not fulfilled, the registration shall include the information specified in Article 10. ...
ARTICLE-18: Registration of transported isolated intermediates [go to this ARTICLE]
... Registration of transported isolated intermediates ...
... 1. Any manufacturer or importer of a transported isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate. ...
... 1. Any manufacturer or importer of a transported isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate. ...
... 2. A registration for a transported isolated intermediate shall include all the following information: ...
... (b) the identity of the intermediate as specified in sections 2.1 to 2.3.4 of Annex VI; ...
... (c) the classification of the intermediate as specified in section 4 of Annex VI; ...
... (d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted; ...
... 3. A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2. For the generation of this information, Article 13 shall apply. ...
... 4. Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions: ...
... 4. Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions: ...
ARTICLE-19: Joint submission of data on isolated intermediates by multiple registrants [go to this ARTICLE]
... 1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, the following shall apply. Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as "the lead registrant"). Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f). ...
... 1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the Community by one or more manufacturers and/or imported by one or more importers, the following shall apply. Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as "the lead registrant"). Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f). ...
ARTICLE-28: Duty to pre-register for phase-in substances [go to this ARTICLE]
... 1. In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance in quantities of 1 tonne or more per year, including without limitation intermediates, shall submit all the following information to the Agency: ...
ARTICLE-49: Further information on on-site isolated intermediates [go to this ARTICLE]
... Further information on on-site isolated intermediates ...
... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...
... For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may: ...
ARTICLE-68: Introducing new and amending current restrictions [go to this ARTICLE]
... 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate. ...
ARTICLE-118: Access to information [go to this ARTICLE]
... (b) without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or preparation, including information about its precise use as an intermediate; ...
ARTICLE-119: Electronic public access [go to this ARTICLE]
... (i) as an intermediate; ...